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ICITRU : Randomized Trial of Immunonutrition With L-citrulline in Patients Hospitalized in Intensive Care for Sepsis or Septic Shock

RecruitingNAAges 18 Years - anyAllRennes University Hospital
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In plain words

What the trial is, and whether it could suit you

Immunonutrition in intensive care has not yet demonstrated a beneficial effect on organ failure, the acquisition of nosocomial infections, or mortality. It did not correct for acquired immunosuppression in intensive care patients. Despite numerous methodological problems (use of several pharmaconutrients, very heterogeneous set of patients) and the absence of clinical data, deleterious effects have been attributed to immunonutrition in intensive care, in particular in septic patients and patients in intensive care . Arginine (ARG) is a semi-essential amino acid involved in many immunological mechanisms. It is synthesized in sufficient quantity under normal conditions but quickly becomes insufficient under catabolic conditions such as in severe sepsis. Arginine is not only the precursor of nitrogen monoxide (NO) but also an essential substrate for numerous enzymatic reactions which partic

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📋 Eligibility rules (as published)
Inclusion Criteria: * Septic patients in accordance with the definition of sepsis and septic shock published in 2016 (JAMA) and whose use is recommended by the European Society of Intensive Care Medicine; * Initial aggression dated less than 4 days before admission to intensive care (selection of "community" patients). The onset of aggression will be defined by the onset of clinical signs of infection; * Patients hospitalized for less than 48 hours before admission to intensive care (selection of patients without malnutrition and immunosuppression acquired in hospital) \*; * Patients under invasive mechanical ventilation with a foreseeable ventilation duration\> 2 days \*\*; * Exclusive enteral nutrition; * Affiliation to a social security scheme; * Consent signed by the patient, relative or legal representative or inclusion under emergency procedure Non Inclusion Criteria: * Progressive Sars-CoV2 infection * Pregnancy in progress; * Morbid obesity (BMI\> 40); * State of immunosuppression defined by at least one of these criteria: continuous administration of steroids at any dose for more than one month before hospitalization, steroids at high doses (\> 0.5 mg / kg / day of methylprednisolone or equivalent), radiotherapy or chemotherapy in the previous year, proven humoral or cellular deficiency; * Contraindication to enteral nutrition (SRLF 2016 recommendations: "Enteral nutrition should probably not be used upstream of a high flow digestive fistula in cases of intestinal obstruction, ischemia of the small intestine or digestive hemorrhage. active (Strong agreement) "); * Participation in intervention research on a drug, or intervention research that could impact the immune system Exclusion Criteria: \- Institution of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high dose corticosteroid therapy (\> 0.5 mg / kg / day ; hydrocortisone used in the management of septic shock is not considered an exclusion criterion).
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What it tests

  • Experimental treatment L-citrulline (Protéocit®)
  • Placebo treatment
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Where

5 sites
Rennes University Hospital - Medical ICU
Rennes, France
Rennes University Hospital - Surgical ICU
Rennes, France
Besançon University Hospital
Besançon, France
Le Mans Hospital
Le Mans, France
Tours University Hospital
Tours, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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